BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 4093857 · Received September 16, 2014

    Report

    Report Number
    2024168-2014-05964
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT RELATED TO A LEAK AT THE Y CONNECTOR WAS ABLE TO BE CONFIRMED THROUGH DEVICE ANALYSIS. IT IS LIKELY DUE TO A FAILURE OF THE BOND, ALLOWING FLUID TO LEAK OUT THE Y CONNECTOR. WHILE A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED LEAKS WAS NOTED BY THE MANUFACTURE. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE HAVE BEEN IMPLEMENTED AND THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL ARMADA REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE DEVICES WERE LEAKING CONTRAST FROM THE HUB AREA, AND NOT WHERE THE SHAFT MEETS THE BALLOON AS ORIGINALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TREATING A LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. DURING PRE-DILATATION, THE 2.0X120MM ARMADA 14 CATHETER DID NOT INFLATE. UPON INSPECTION AFTER REMOVING THE BALLOON FROM THE ANATOMY, THE DEVICE WAS FOUND TO BE LEAKING CONTRAST FROM WHERE THE SHAFT MEETS THE BALLOON. THE 2.0X80MM ARMADA 14 CATHETER WAS THEN USED AND WOULD NOT INFLATE. UPON INSPECTION AFTER REMOVING THE BALLOON FROM THE ANATOMY, THIS DEVICE WAS ALSO FOUND TO BE LEAKING CONTRAST FROM WHERE THE SHAFT MEETS THE BALLOON. A 2.0X80MM FOX SV WAS THEN USED FOR SUCCESSFUL PRE-DILATATION AND THE PROCEDURE WAS SUCCESSFUL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570762 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 725849

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR